RecruitingPhase 2NCT06121180

Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma

A Phase II Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

32 participants

Start Date

Nov 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical research study is to find out if Cemiplimab plus Ziv-Aflibercept is safe and effective in treating your condition of metastatic (spread to other parts of your body) uveal melanoma. This research study will test the study drugs to see if the combination of Cemiplimab plus Ziv-Aflibercept can make tumors shrink or stop growing.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — cemiplimab (an immunotherapy) and ziv-aflibercept (a drug that blocks blood vessel growth feeding the tumor) — for people with metastatic uveal melanoma, a rare type of eye cancer that has spread to other organs, as well as certain other advanced melanomas. **You may be eligible if...** - You have metastatic uveal melanoma (eye melanoma that has spread) - Or you have advanced cutaneous, mucosal, or unknown primary melanoma that has progressed after prior anti-PD-1 immunotherapy - You are 18 or older with a life expectancy of more than 3 months - You are in good overall health (ECOG 0 or 1) with measurable disease - Your kidney protein levels and heart function are within acceptable ranges **You may NOT be eligible if...** - You have very poor organ function - Your urine protein levels are too high (500 mg or more in 24 hours) - You have uncontrolled bleeding or a condition that puts you at high risk of bleeding - Your heart's pumping function is abnormal Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZIV-Aflibercept

Ziv-Aflibercept is an investigational or experimental anti-cancer agent inactivates vascular endothelial growth factor (VEGF) from functioning and scientific experiments have shown that when VEGF is prevented from working, new blood vessels don't form in tumors and these tumors do not grow. In addition, VEGF has been shown to have a negative effect on the immune response and blocking it may help the immune response against cancer.

DRUGCemiplimab

Cemiplimab is a human monoclonal anti-PD-1 antibody that works by blocking the programmed death-1 (PD-1), a cell receptor on immune cells that is involved in preventing immune cells from destroying other cells. Blocking the receptor is expected to help immune cells attack cancer cells.


Locations(4)

The Angeles Clinic and Research Institute

Los Angeles, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Northwell Health Center for Advanced Medicine

New Hyde Park, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06121180


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